Cold is undeniably the new normal for the biopharmaceutical industry. By 2020, greater than half of bestselling drugs will be cold-chain products, most of which are injectable.
When a clinical trial progresses, the formulation itself and the dosage form may change. As a result, sponsors may also want to consider the desirable commercial format in later stage clinical studies.
In the pharmaceutical industry, “technology transfer” refers to the processes that are needed for successful progression of stages ranging from drug discovery, product development, clinical trials to full-scale commercialization or it is the transfer between development and commercialization at different sites within or outside an organization.
Experience has shown the transition from active shippers to passive shippers is mainly driven by three factors: cost-savings, availability, and ease of use.
Supply chain integrity is necessary to a pharmaceutical company’s success. When dealing with a multitude of suppliers spanning several geographies, manufacturing issues can arise if proper protocols are not in place. Specific challenges include product purity, regulatory compliance, safety, cost containment and quality assurance.
Audit processes are an integral component of supply chain management. Conducting an effective audit empowers pharmaceutical companies and their suppliers to raise performance levels and strengthen relationships while improving patient-care quality. The mutual benefits of a successful audit include:
SAFC’s CHOZN® Platform has been developed as a ‘plug and play’ manufacturing system for the creation of biopharmaceutical producing cell lines.
A whitepaper describing how a Unified Approach enhances the safety, simplicity and speed of clinical trials.
Alkermes, through the merger with Elan Drug Technologies, to become Alkermes plc, has been developing and manufacturing commercial scale solid oral dosage products for over 40 years.
Two unique techniques, saccadic eye movements and pupillometry, help characterize pharmacodynamic drug effects in healthy subjects. This article explores how these techniques are being applied to investigate the side-effect profile of compounds, better understand the mechanisms involved in the pathophysiology of CNS disease states, and demonstrate target engagement of drugs.
Many different public and private organizations from across the globe are collaborating on neglected diseases drug-discovery and development projects with the aim of identifying a cure for tropical infectious diseases.
Ropack's portfolio of primary pharmaceutical packaging methods meets the highest quality and safety standards.
Hard work is just part of the Ropack ethos, and we prove it daily through our output: high-capacity turnover that does not compromise our quality or excellence. All estimates based on three six-hour shifts per day.
Our cutting-edge technology and impeccable standards ensure that our customers receive products that meet their exact needs.
Bottles are sealed with induction seals, permaseals, and child-resistant or senior-friendly caps. Ropack is your leader for contract packaging and solid dose bottling services.
Stick-pack uni-dose packing, globally accepted for its accuracy, convenience and cost-savings, is now available in North America from Ropack. A 15,000-square-foot Class 100000 dedicated facility ensures a controlled production environment for your contract packaging needs.
Once material is packaged, secondary packaging is a crucial part of the preparation process. Ropack doesn’t leave anything to chance, with secondary contract packaging services to ensure your products are ready for market when you need them to be.
Ropack provides a number of contract blister packaging services and can produce blister packaging in several different forms, including regular thermo-form, cold-formed, and heat-sealed blister cards.
Hard work is just part of the Ropack Pharma Solutions ethos, and we prove it daily through our output: high-capacity turnover that does not compromise our quality or excellence. We provide ample capacity and bring agility, efficiency and gold-standard technology to the manufacturing and packaging of solid oral dosage forms for clinical and commercial pharmaceutical applications and commercial nutraceuticals.
Contract manufacturing and packaging services that bring your vision to market.
Contract packaging for pharmaceutical and consumer health-care is Ropack’s core service. Global customers rely on our exacting production environments — 32 Class 100000 Clean Rooms, including a new dedicated stick-pack production facility ensuring low RH and controlled temperature.
